EUCTR2017-001683-37-FR进行中（未招募）1 期
SecOnd-line Chemotherapy with RAmucirumab +/- pacliTaxel in Elderly advanced gastric or gastroesophageal junction cancer patients - SOCRATE
Fédération Francophone de Cancérologie Digestive0 个研究点目标入组 112 人开始时间: 2018年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whatever HER2 status
- •Aged = 70 years
- •Estimated life expectancy > 3 months
- •Measurable or non-measurable disease according to RECIST 1.1 criteria
- •Documented progression during first-line fluoropyrimidine- and platinum- or irinotecan containing chemotherapy (with or without anthracycline), or during the 4 months following the last cycle of such chemotherapy administered for metastatic or locally advanced disease, or during the 6 months following the last dose of adjuvant therapy containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed)
- •Adequate hepatic, renal and hematologic function:
- •oANC = 1 500 / mm3, platelets = 100 000 / mm3, hemoglobin = 9 g/dL
- •oBlood creatinine = 1.5 x ULN and creatinine clearance (MDRD formula) = 40 mL/min
- •oTotal bilirubin = 1.5 x ULN, AST and ALT = 3 x ULN (= 5 x ULN if hepatic metastasis)
- •oINR = 1.5 or INR = 3 for patients taking AVK and PTT = 5 seconds above the ULN
- •oDipstick proteinuria = 1+ or 24 hour proteinuria < 1 g in total
- •EORTC QLQ-C30 + QLQ-ELD14, completed and faxed to the Randomization, Management and Analysis Center of the FFCD
- •IADL geriatric questionnaire, completed and faxed to Randomization Management and Analysis Center of FFCD
- •Signed informed consent ?
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 112
排除标准
- •Known cerebral metastasis
- •Prior treatment by taxanes
- •Prior treatment with an antiangiogenic
- •Neuropathy of grade = 2 (NCI-CTCAE 4.0)
- •Unresolved partial or total bowel obstruction, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or extensive gastrointestinal (GI) resection combined with chronic diarrhea
- •GI perforation and/or fistulae in the 6 months preceding randomization.
- •GI bleeding within the last 3 months of grade = 3 (NCI-CTCAE 4.0)
- •Chronic use of antiplatelet drugs (including aspirin, but a daily intake of = 325 mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen), dipyridamole, clopidogrel or similar agents
- •Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) in the 6 months preceding randomization
- •A life-threatening episode of pulmonary embolism in the 6 months preceding randomization
- •Deep-vein thrombosis, pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant” during the 3 months prior to first dose of protocol therapy
- •Uncompensated congestive heart failure or uncontrolled arrhythmia
- •Uncontrolled hypertension (= 160/100 mm Hg for > 4 weeks) despite properly observed antihypertensive therapy
- •Cirrhosis at a level of Chilg-Pugh B or C; or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
- •Serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization
- •Radiotherapy or major surgery within 28 days of prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior the first dose of protocol therapy
- •Known allergy to paclitaxel or ramucirumab
- •Another concomitant cancer or a history of cancer in the last 5 years, except cervical carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other carcinoma in situ deemed to be successfully treated
- •Persons deprived of liberty or under supervision
- •Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons
研究者
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